Passeo-35 7/40/80Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-35 (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640119558196), received between Jan 27, 2020 and Jan 27, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Puncture/Hole2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2020Material Puncture/Hole; Material Puncture/Hole
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE ILIAC ARTERY. THE DEVICE WAS PLACED IN THE TARGET LESION. DURING INFLATION AT 5 BAR, THE BALLOON LOST PRESSURE. AFTER REMOVAL, A PINHOLE WAS DETECTED. A SECOND PASSEO-35 WITH SAME SIZE BUT ANOTHER LOT NUMBER WAS USED AND THE SAME PROBLEM OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9631865 ↗MalfunctionJan 27, 2020Material Puncture/Hole; Material Puncture/Hole
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE ILIAC ARTERY. THE DEVICE WAS PLACED IN THE TARGET LESION. DURING INFLATION AT 5 BAR, THE BALLOON LOST PRESSURE. AFTER REMOVAL, A PINHOLE WAS DETECTED. A SECOND PASSEO-35 WITH SAME SIZE BUT ANOTHER LOT NUMBER WAS USED AND THE SAME PROBLEM OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9631855 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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